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What Do Legal Challenges on Gene Patents Mean for Neurology?

A legal challenge to the patent on two genes associated with breast cancer and ovarian cancer and a federal policy review of gene patents are stirring up discussion among neurologists about the role of patents in patient care and research.

The lawsuit, organized by the American Civil Liberties Union (ACLU) against Myriad Genetics and the Patent Office, charges that patents on the genes — BRCA1 and BRCA2— and on the testing that detects those genes is unconstitutional.

Plaintiffs include the Association for Molecular Pathology, the American College of Medical Genetics, the American Society of Clinical Pathology, and the College of American Pathologists, along with other researchers, patient advocacy groups, genetic counselors, and individual patients.

“Since the constitution established the right to patent several centuries ago, it has been a rule of patent law that you cannot patent products of nature, laws of nature, or abstract ideas,” said Chris Hansen, a staff attorney at the ACLU. “It is our view that human genes fall into these categories and therefore should never have been patented.”

LEGAL PRECEDENTS

Patents provide 20 years of protection from outside competition, starting from the time the patent is filed. Gene patents have been issued since the US Supreme Court's 1980 decision in Diamond v. Chakrbarty that genetically engineered bacteria were patentable because even though they were alive, they were synthetic and did not occur naturally on their own.

Myriad and other proponents of the patent system have argued in published reports that the temporary monopoly provided by a patent gives companies an incentive to invest in research and development.

“An isolated gene is different from what is found in nature,” said Bill Warren, a partner and the chair of the life sciences division at Sutherland, an Atlanta-based law firm. “A gene found in the human body is isolated and manipulated for the purpose of making the test. Saying you can't patent a gene is analogous to saying that insulin is naturally found in the body and therefore the isolated protein is not patentable subject matter either.”

The federal government is also weighing the question of gene patents. In 2007, the House Judiciary Subcommittee on Courts, the Internet and Intellectual Property held hearings on the role of gene patents in research and genetic testing. Earlier this year, the Health and Human Services Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) collected public comments on a draft report on gene patents and licensing practices. (See http://bit.ly/XvUX9 for the report and public comments.)

The SACGHS report included case studies of ten diseases, including Alzheimer disease, spinocerebellar ataxia, and long QT syndrome, to see how gene patents influence cost, access to, and availability of genetic tests. The report also assessed the impact of gene patents on research. According to the report, there wasn't much consistent evidence that gene patents had a positive or negative effect on patient access to genetic tests, but patents could possibly limit access in the future.

Among recommendations, the SACGHS committee suggested developing a code of conduct to give patients better access to genetic tests, as well as efforts to enhance transparency in patents and licensing and to allow more data on gene patenting and licensing to be gathered.

CONCERNS ABOUT LICENSING

Katherine D. Mathews, MD, director of the division of pediatric neurology at the University of Iowa Children's Hospital in Iowa City, has testified before Congress and submitted comments on the SACGHS report. She said she is most concerned with how gene patents are applied. When a patent holder, typically a research university, grants an exclusive license, only the license holder can use the patent for genetic testing. “It's the exclusive licensing of the patents that's had the most dramatic impact on my patients,” she said.

She said that in the past, she could choose among several laboratories that offered genetic testing for diseases she treats in her practice, including spinocerebellar ataxia, Charcot-Marie-Tooth disease, and Duchenne muscular dystrophy. She became involved with the debate over access to genetic testing after she noticed a recurring situation with her patients. She would order a test, only to find out that many laboratories she relied on were no longer offering it. “I was shocked that I couldn't switch labs, and good labs were discontinuing the testing, so I went to figure out why,” she said.

Dr. Mathews said she discovered that the companies with exclusive licenses for the genetic tests were sending out cease-and-desist letters to competing laboratories, leading them to shut down. “I used to have a lot of options, now I have one option,” she said. “Before, if I didn't like the way the report read or if there were problems with billing or paperwork, I could go to another lab. Now I can't.”

“Exclusive licensing has also made genetic testing too costly for many patients, many of whom are already disabled and not in the mainstream of economic life,” said Teepu Siddique, MD, professor of neurology at Northwestern University and the chair of the AAN Neurogenetics Section. “Each time you do a test, it's a thousand bucks. Who can afford it?”

Dr. Mathews said that laboratories may offer a panel of tests for all the genes associated with a particular disease, at a cost of $10,000 or more, with a financial disincentive for ordering tests for individual genes. Some laboratories don't take Medicaid and Medicare. “There's no motivation to bring down costs because there's no competition,” she said.

Attorney Bill Warren pointed out that patents allow only a limited period of time for a monopoly, and companies will, as they have with other patented inventions, identify “a reasonable price that consumers are willing to pay” during that period.

As for quality concerns, “there are other means for quality control, if that's a concern, rather than eliminating the patent system,” Warren said. “The FDA is looking at expanding the scope of review and approval of diagnostics to control the quality.”

It is up to the patent holder to decide whether to grant one exclusive license for a gene test or to opt for nonexclusive licenses, said Eric P. Hoffman, PhD, director of the Research Center for Genetic Medicine at the Children's National Medical Center in Washington, DC. He explained that when a patent holder permits nonexclusive license, all the laboratories that wanted to offer testing for a certain gene could get a license from the patent holder, in exchange for a fee and royalties.

Dr. Hoffman said that exclusive licenses have become an increasingly popular business model, pioneered by Athena Diagnostics, a leading provider of neurological genetic testing, based in Worchester, MA. “It can be intoxicating to a university if a company comes and says we'll give you a lot of money for an exclusive license, instead of beating the bushes finding all these nonexclusive licenses,” he said.

Dr. Mathews said her concerns about exclusive licensing and gene patents will only become more pressing as neurology becomes increasingly reliant on genetic testing. “Treatments will be modified by genetic testing, and genetic backgrounds will modify how we dose drugs,” she said. “If we are dependent on a single lab, I think our ability to provide services to patients will be severely compromised.”

Dr. Hoffman commented that many of the SACGHS draft recommendations might be out of date by the time they're implemented. He pointed out that within a year or two, the “$1,000 genome” test will be a reality, allowing researchers and practitioners to sequence every nucleotide of a patient's DNA at once using next-generation sequencing technology.

“When a patient comes in to a neurology clinic with a problem that is genetic, instead of trying to pick out and guess from a menu of causative genes, you just get everything sequenced for less than what one gene would cost,” Dr. Hoffman said.

But, he added, anyone who has an exclusive license on any of the genes sequenced could shut such a test down with a cease-and-desist order. “At some point, look, it's everybody's genome, it's everybody's test, so just open it up to what's cost effective, accurate, and gives access,” Dr. Hoffman said. “The more the technology develops, the less exclusive licenses are tenable with where things are going.”

GOVERNMENT'S ROLE

The policy options detailed in the SACGHS report include the possibility of clarifying the authority of the Department of Health and Human Services to require that “any inventions resulting from government funding [to be] licensed nonexclusively when they are licensed for the genetic diagnostic field of use.”

Dr. Mathews said she supports the idea. “If genes are found with federal money, then there shouldn't be such restrictive limitations on the use of that genetic information for clinical care,” she said. “Many different labs should be able to offer clinical testing that results from identifying that gene since that competition benefits the public.”

But Dr. Siddique said that genes should not be patented at all — and if they are, the time limit should be short, because most discoveries are made through federal funding, which comes from taxpayer money. “It really limits the development of new treatments,” he said. “If you are not a big company and you don't have capital funding, but have good ideas, how are you going to do the development of new therapies because you need to pay the licensing fee? If you have a good idea, it's not going to work because of financial impediments.”

Dr. Siddique said gene patents are an example of “science for sale” — the incursion of corporate thinking into research. “These are insidious and pernicious partnerships created between companies and universities that diverts away the attention of the scientists from what needs to be done in society,” he said.

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